小型會議/研討會

Pre-conferences symposium W - 在土耳其市場成功的條件：關於法規的最新資訊與有效進入市場

2012年10月8日(星期一)

Registration is at 13:30 for a 14:00 start. The workshop will finish no later than 20:00, followed by an evening networking dinner. Workshop documents will be provided.

The market in Turkey is growing and prospects are excellent. This workshop will provide an essential update of the regulatory requirements in Turkey, registration requirements and a real life industry case study for successful market access will be presented.  

Essential regulatory update and registration requirements in Turkey

• Examining the current up-to-date regulatory environment in Turkey
• Assessing whether Turkey is transporting new European regulations and how aligned they are to the EU
• Clarifying whether Turkey accepts the CE mark and whether additional documentation is required
• Examining the key differences between the regulatory systems in Turkey and the EU
• Examining whether Turkey is planning to become more aligned with the EU in the near future
• Exploring the challenge of the requirement of a unique product number during registration
• Examining whether Turkey comply to European environment requirements REACH and WEEE

Real life industry case study for successful market access in Turkey

• Practical advice on how to get a product approved successfully on the market in Turkey
• Experience of language challenges in Turkey: Should a label or operator manual be in Turkish or can it be in English?
• Examining specific labelling requirements in Turkey in terms of label content
• Discussing the challenges of relying on a distributor for language translation in Turkey

Reviewing the challenge of reimbursement in Turkey

• Exploring the challenging reimbursement process in place in Turkey
• Practical advice on how to overcome this reimbursement challenge
• Understanding the pre-requirements in place for reimbursement in Turkey
• Examining the use of the Global Medical Device Nomenclature (GMDN) for the purpose of reimbursement in Turkey

Olgun Sener, Education Expert/Public Administration Expert, Ministry of Health, Turkey

Guvenc Kokaya, Healthcare Economics and Reimbursement Manager, Covidien, Turkey

Gozdem Delipinar, Quality Assurance and Regulatory Affairs Manager, Alvimedica. Turkey

Post-conferences symposium X - 在中東市場成功的條件：關於法規的最新資訊與有效進入市場

2012年10月11日（星期四）

Registration is at 08:30 for a 09:00 start. The workshop will finish no later than 16:00. Workshop documents, refreshments and lunch will be provided.

The Middle Eastern market is displaying outstanding growth and is making excellent progress. This workshop will cover a crucial regulatory update and practical industry case study for successful market access in the attractive markets of Saudi Arabia and the United Arab Emirates. An overview of regulatory requirements in Egypt, Kuwait and Jordan will also be covered.

Essential regulatory update for medical devices and IVDs in Saudi Arabia

• Critical overview of the new regulations on medical devices from the SFDA
• Examining what is in the pipeline in terms of regulations in Saudi Arabia
• Exploring Saudi Arabia’s practice of accepting products that are authorised under the main global regulations and the impact this has on industry
• Exploring the use of Conformity Assessment Bodies (CABs) in Saudi Arabia and how this impacts industry
• Assessing whether clinical trials are mandatory in Saudi Arabia
• Determining whether other countries are planning to follow Saudi Arabia in the steps it has taken with the new regulations

Practical industry case study on complying with new regulations and successful market access in Saudi Arabia

• Reviewing the key challenges experienced by manufacturers in implementing the new regulations
• Exploring the challenges associated with registration and getting product approval in Saudi Arabia
• Determining what is mandatory regarding a submission
• Reviewing timelines and deadlines associated with the completion of a dossier
• Discussing the challenge of using an authorised person in Saudi Arabia to assist with registration
• Practical advice on how to overcome these challenges, remain compliant and achieve successful submission in Saudi Arabia

Essential regulatory update for medical devices and IVDs in the United Arab Emirates

• Essential regulatory update for compliance in the United Arab Emirates
• Exploring new regulations in the pipeline for the United Arab Emirates
• Assessing whether clinical trials are mandatory in the United Arab Emirates
• Determining whether other countries are planning to follow Saudi Arabia in the steps it has taken with the new regulations

Practical industry case study on complying with regulations and successful market access in the United Arab Emirates

• Practical experience of the challenges faced in implementing the medical device regulations in the United Arab Emirates 
• Reviewing the key challenges experienced with registration in the United Arab Emirates 
• Determining what is mandatory regarding a submission
• Reviewing timelines and deadlines associated with the completion of a dossier
• Discussing the difficulty obtaining regulatory information from authorities in the United Arab Emirates
• Practical advice on how to overcome these challenges, remain compliant and achieve successful submission in the United Arab Emirates

Essential regulatory update from Egypt, Kuwait and Jordan

• Exploring an up-to-date review of regulations from these countries
• Assessing registration challenges in Egypt: Specific requirements for certification
• Exploring any new regulations in the pipeline for these countries

Norbert Stuiber, Operations Manager MHS, TUV SUD Middle East, Saudi Arabia

Claudia Ising, Head of Regulatory Affairs, Lohmann & Rauscher, Germany

傍晚研討會 Y - 在俄羅斯和其他CIS各國臨床面之重要的討論課題

2012年10月9日(星期二)

Registration is at 18:00 for an 18:15 start. The seminar will finish no later than 20:30. Seminar documents and an evening networking dinner will be provided.

Essential clinical considerations in Russia and other CIS countries

This seminar will cover an essential regulatory update for carrying out clinical trials in Russia and other CIS countries as well as a real life industry case study and practical advice for clinical trials being carried out in these countries.

Regulatory update: Clinical trials in Russia and other CIS countries

• An update on clinical trial requirements in these countries
• Assessing clinical validity studies in these countries
• Exploring the key differences in clinical methodology in these different country areas
• Discussing whether and when clinical trials are mandatory in these areas
• Assessing whether Russia and CIS countries are following the updated ISO 14155
• Exploring whether Russia and CIS countries follow the ICH GCP (Good Clinical Practice) and if not, what are the alternative requirements

Real life industry case study: Clinical trials in Russia and other CIS countries

• Real life examples of devices that have been submitted for which clinical trials have to be done
• Key challenges that were experienced in clinical trials
• Practical advice on how to overcome these challenges
• Exploring similarities and differences in clinical trials in these countries compared to experiences in Europe

Seminar leader to be confirmed